Effects of Endotoxin Absorption and Cytokine Removal Hemofilter on Severe Septic Shock

Not Applicable

Completed

• Conditions: Sepsis, Severe; Septic Shock
• Interventions: Device: oXiris blood purification set

• Registration Number: NCT03974386
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

In recent years, many studies have pointed out that bacterial toxin and cytokine storm are the main causes of shock and multiple organ failure in patients with sepsis. Endotoxin is the main vehicle for systemic inflammatory reaction caused by gram-negative bacteria which induce sepsis. Endotoxin binds to Toll- Like receptor 4 (TLR4) trigger a cytokine storm. The amount of endotoxin is associated with shock, insufficient intestinal perfusion, and poor prognosis. Therefore, clinicians try to use various methods to antagonize the action of endotoxin, which can reduce the cytokine storm and inflammatory response to improve the prognosis of sepsis.

Continuous venous venous hemofiltration plays a role in blood purification in septic shock. With different hemofiltration filters, it has different effects. By removing the inflammatory mediators caused by bacterial toxins and cytokines, shock can be improved. The study plans to receive patients with septic shock and use a hemofiltration filter that adsorbs endotoxin and removes cytokines (oXiris, Baxter Healthcare) to perform continuous venous venous hemofiltration in addition to basic septic shock resuscitation. The effect on the concentration of cytokines in the blood, the infusion dose of inotropics, the fluid balances, and the degree of organ damage was evaluated. It is hoped that the results of this pilot study can lead us to subsequent randomized clinical trials to explore whether this filter can improve the prognosis of septic shock patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-02
• Study First Submitted QC: 2019-06-02
• Study First Posted: 2019-06-04
• Study Start: 2019-07-01
• Primary Completion: 2020-07-17
• Study Completion: 2020-08-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patients who meet all criteria (A+B+C):
• A) Identified infection source under adequate treatment
• B) Sepsis (the sequential organ failure assessment score rise 2 points or more)
• C) Severe septic shock (serum lactate > 2 mmol/L; need continuous norepinephrine infusion to maintain adequate blood pressure, of which dosage is > 0.2 mcg/kg/min for more than 1 hour or >0.1 mcg/kg/min for more than 3 hours )

Read More

Exclusion Criteria

• Onset of severe septic shock more than 24 hours
• Received continuous renal replacement therapy within 24 hours before enrollment
• Serum white blood cell count count < 1000 cells/μL or Platelet count < 50000 cells/μL
• History of allergy to heparin
• Received cardiopulmonary resuscitation within 4 weeks before enrollment
• ICU admission due to severe septic shock within 2 months
• Patients or Family had chosen palliative care and signed an agreement to deny aggressive treatment
• Pregnancy
• APACHE II Score > 30 at enrollment
• Non-native speakers

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood Purification	oXiris blood purification set	Patients will receive resuscitation and treatment according to current guidelines for septic shock. In addition to standard care, the patients will receive continuous venovenous hemofiltration and adsorption with oXiris blood purification set.

Primary Outcome Measures

Name	Time	Method
Difference of serum interleukin-6 level	24 hours	Comparison to enrollment or between 2 groups

Secondary Outcome Measures

Name	Time	Method
Difference of serum interleukin-10 level	72 hours	Comparison to enrollment or between 2 groups
Difference of mean arterial pressure	72 hours	Comparison to enrollment
Difference of norepinephrine infusion rate	72 hours	Comparison to enrollment
Difference of serum procalcitonin level	72 hours	Comparison to enrollment or between 2 groups
Difference of serum interleukin-1β level	72 hours	Comparison to enrollment or between 2 groups
Difference of cardiac output	72 hours	Comparison to enrollment
Difference of the sequential organ failure assessment score	72 hours	Comparison to enrollment or between 2 groups
Difference of serum endocan level	72 hours	Comparison to enrollment or between 2 groups
Difference of serum interleukin-6 level	72 hours	Comparison to enrollment or between 2 groups
Difference of daily IV fluids	72 hours	Comparison between 2 groups
Difference of serum diamine oxidase level	72 hours	Comparison to enrollment or between 2 groups

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan